Nuvis

FDA UDI

Class II (US FDA UDI)

by Integrated Endoscopy, Inc.

Identity

Trade Name: Nuvis FDA UDI
Generic Name: Rigid optical arthroscope, reusable FDA UDI
Device Name: The Nuvis® Arthroscope is a non-deflectable rigid endoscopic optical instrument designed for illumination and visualization of internal anatomy of a patient within the knee, shoulder, hip, wrist, temporal mandibular joint, ankle, elbow, and feet joints. Integrated Endoscopy’s Nuvis Arthroscope has a 142mm working length, an outside diameter of 4mm, a field of view of 105°, and a direction of view of 30°. The Arthroscope is designed to be used with a cannula compatible with a 4mm x 30° arthroscope with a working length of 142mm. The Arthroscope is supplied sterile and is for single-use only. It is not intended to be re-used or re-sterilized. FDA UDI
Model / Reference: IE4030 FDA UDI
Description: The Nuvis® Arthroscope is a non-deflectable rigid endoscopic optical instrument designed for illumination and visualization of internal anatomy of a patient within the knee, shoulder, hip, wrist, temporal mandibular joint, ankle, elbow, and feet joints. Integrated Endoscopy’s Nuvis Arthroscope has a 142mm working length, an outside diameter of 4mm, a field of view of 105°, and a direction of view of 30°. The Arthroscope is designed to be used with a cannula compatible with a 4mm x 30° arthroscope with a working length of 142mm. The Arthroscope is supplied sterile and is for single-use only. It is not intended to be re-used or re-sterilized. FDA UDI

Identifiers

Catalog Number: IE4030 FDA UDI
Primary DI / UDI-DI: 00853816008001 FDA UDI
510(k) Number: K191594 FDA UDI
FDA Product Code: HRX FDA UDI
GMDN Term: Rigid optical arthroscope, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.1100 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Angle — 30 degree FDA UDI
Outer Diameter — 4 Millimeter FDA UDI
Length — 142 Millimeter FDA UDI

Category: Rigid optical arthroscope, reusable

Nuvis by Integrated Endoscopy, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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HOPKINS — Karl Storz GmbH & Co. KG · Class II
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Cleared under the same submission

K191594 also covers:

Nuvis — Integrated Endoscopy, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Integrated Endoscopy, Inc.

Sources (1)

FDA UDI f6ea5756-3f4e-413a-93dd-bcfec5e40e0f 37 fields · synced Jun 8, 2026